Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT02867202
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2016-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007434', 'term': 'Intrauterine Devices'}], 'ancestors': [{'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zfy983023@hotmail.com', 'phone': '0886-0577-88069525', 'title': 'the 1st affiliated hospital of Wenzhou Medical University.', 'organization': 'the 1st affiliated hospital of Wenzhou Medical University.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months to 1 year', 'description': 'Among 171 participants who were initially recruited, 18 were excluded from analysis; 8 patients declined to participate and 10 patients did not meet the inclusion criteria. 30 participants subsequently refused to undergo the second-look hysteroscopy, and 5 subjects were also excluded for protocol violation. 17 women in the study reported side effects. 15 subjects suffered from moderate to severe postoperative pain; 12in the COOK balloon stent group and 3 in the IUD plus Foley catheter group.', 'eventGroups': [{'id': 'EG000', 'title': 'Intrauterine Balloon', 'description': 'After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 21, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IUD Plus Foley Catheter', 'description': 'Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 32, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'suffered from moderate to severe postoperative pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'refuse to have second-look hysteroscopy', 'notes': 'excluded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Protocol violation', 'notes': 'excluded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Declined to participate', 'notes': 'excluded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Not meeting inclusion criteria', 'notes': 'excluded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2.3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the AFS Score at Second-look Hysteroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intrauterine Balloon', 'description': 'The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.\n\nIntrauterine balloon: After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.'}, {'id': 'OG001', 'title': 'Intrauterine Device Plus Foley Catheter', 'description': 'Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while Intrauterine Device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.\n\nIntrauterine Contraceptive Device Plus Foley Catheter: After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \\< 0.05 was considered statistically significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '2 or 3 months after the surgery', 'description': 'The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intrauterine Balloon', 'description': 'After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.'}, {'id': 'FG001', 'title': 'Intrauterine Contraceptive Device Plus Foley Catheter', 'description': 'Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'all patients were recruited from 1st affiliated hospital of Wenzhou Medical University.\n\nInclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)', 'preAssignmentDetails': '1. not meeting inclusion criteria\n2. declined to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intrauterine Balloon', 'description': 'After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.'}, {'id': 'BG001', 'title': 'IUD Plus Foley Catheter', 'description': 'Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.69', 'spread': '5.268', 'groupId': 'BG000'}, {'value': '32.63', 'spread': '6.125', 'groupId': 'BG001'}, {'value': '32.14', 'spread': '5.685', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '0.484', 'spread': '0.565', 'groupId': 'BG000'}, {'value': '0.554', 'spread': '0.536', 'groupId': 'BG001'}, {'value': '0.517', 'spread': '0.551', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Births', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-01', 'size': 174110, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-12-27T06:38', 'hasProtocol': False}, {'date': '2017-12-01', 'size': 91769, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-09T08:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-15', 'studyFirstSubmitDate': '2016-04-11', 'resultsFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-15', 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the AFS Score at Second-look Hysteroscopy', 'timeFrame': '2 or 3 months after the surgery', 'description': 'The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intrauterine balloon', 'Intrauterine Device Plus Foley Balloon Catheter', 'Asherman Syndrome'], 'conditions': ['Asherman Syndrome']}, 'referencesModule': {'references': [{'pmid': '25936237', 'type': 'BACKGROUND', 'citation': 'Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.'}, {'pmid': '23933351', 'type': 'BACKGROUND', 'citation': 'Johary J, Xue M, Zhu X, Xu D, Velu PP. Efficacy of estrogen therapy in patients with intrauterine adhesions: systematic review. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):44-54. doi: 10.1016/j.jmig.2013.07.018. Epub 2013 Aug 9.'}, {'pmid': '23932377', 'type': 'BACKGROUND', 'citation': 'Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.', 'detailedDescription': 'Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.\n\nThe Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.\n\nThe heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe intrauterine adhesion (AFS score ≥5）\n* Agreement to have a second-look hysteroscopy\n* no previous history of hysteroscopic adhesiolysis\n\nExclusion Criteria:\n\n* Minimal adhesion (AFS score\\<5)\n* Previous hysteroscopic adhesiolysis'}, 'identificationModule': {'nctId': 'NCT02867202', 'briefTitle': 'Adjuvant Therapy for Intrauterine Adhesions Between Two Groups', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis', 'orgStudyIdInfo': {'id': 'Wenzhou MC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrauterine balloon', 'description': 'The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.', 'interventionNames': ['Device: Intrauterine balloon']}, {'type': 'EXPERIMENTAL', 'label': 'intrauterine device Plus Foley Catheter', 'description': 'Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.', 'interventionNames': ['Device: Intrauterine Contraceptive Device Plus Foley Catheter']}], 'interventions': [{'name': 'Intrauterine balloon', 'type': 'DEVICE', 'otherNames': ['Cook balloon'], 'description': 'After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.', 'armGroupLabels': ['Intrauterine balloon']}, {'name': 'Intrauterine Contraceptive Device Plus Foley Catheter', 'type': 'DEVICE', 'otherNames': ['Intrauterine Device Plus Foley Catheter'], 'description': 'After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.', 'armGroupLabels': ['intrauterine device Plus Foley Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the 1st Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Feng Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 1st Affiliated Hospital of Wenzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending doctor', 'investigatorFullName': 'Feng Lin', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}